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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

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COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Model Number G25149
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 05/29/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. The device was returned with the basket partially extended out of the catheter lumen. There was no fluid in the catheter lumen. One of the wires on the basket had broken loose from the distal end of the basket and was still attached at the proximal end of the basket. A production meeting was held on (b)(6) 2019, the distal tip of the wire was examined under magnification and it was determined that the wire had been damaged by the buff process. No part of the device was missing. No other anomalies were detected. The device history records for the wire guide lot was reviewed. The extraction basket device history record contains a nonconformance that could potentially be related to basket wire breaks. A record of notification was issued to production management and the department leaders in response to this report. Investigation conclusion: it was confirmed that the device was broken due to damage done to the basket wire during the buff process. This occurred due to operator error. Production management and the department team leads were notified of this occurrence. Additionally, a notification of operator related complaint form was provided to production management to make them aware of an operator related complaint. Re-training with the operator was completed on (b)(6) 2019. Prior to distribution, all memory ii double lumen extraction baskets are subjected to a visual inspection to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. The operator was retraining on the associated processes. No additional corrective action is warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
 
Event Description
In preparation for an endoscopic procedure, the physician selected a cook memory ii double lumen extraction basket. Upon opening the package of the device, the user noticed that the basket wire was already broken. Therefore, another manufacturer's basket device was used instead. This occurred prior to patient contact; there was no impact to the patient.
 
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Brand NameMEMORY II DOUBLE LUMEN EXTRACTION BASKET
Type of DeviceFFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key8732626
MDR Text Key152096100
Report Number1037905-2019-00350
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002251496
UDI-Public(01)00827002251496(17)220405(10)W4200526
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/05/2022
Device Model NumberG25149
Device Catalogue NumberMB-35-2X4-8
Device Lot NumberW4200526
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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